Sr. Specialist Cell Therapy Manufacturing

3 weeks ago

Durham, United States CARsgen Therapeutics Full time

CARsgen Therapeutics is seeking a highly motivated professional with Cell Therapy and/or Cell Culture manufacturing experience. This role will support production and facility start-up initiatives for our clinical stage CAR-T Cell therapy products at our RTP, North Carolina facility.

Responsibilities:

  • Daily manufacturing of cell therapy products in a Grade A (Biological Safety Cabinet)/Grade B clean room environment, including open manipulations and use of cell processing equipment.
  • Act as subject matter expert (SME) for related manufacturing operations and equipment and be able to provide on the floor support.
  • Author and revise Standard Operating Procedures (SOPs), manufacturing batch records, and other related documents in accordance with GMP requirements and regulations.
  • Initiate and manage Deviation, CAPA, Change Control, and Effectiveness verification reports and ensure all action items are completed in a timely manner.
  • Coach and train team members ensuring proper Aseptic Technique, clean room behavior, and compliance with written procedures
  • Lead process improvement initiatives in collaboration with Manufacturing Science and Technology (MSAT) and quality departments.
  • Maintain a high level of accountability and integrity
  • Support Regulatory Audit activities as a manufacturing department SME and representative and ensure audit readiness of respective area

Qualifications:

  • Bachelor’s degree in relevant science or engineering discipline.
  • 4+ years’ experience with cGMP biologics manufacturing and/or commercial cell therapy operations.
  • Experience with CAR-T manufacturing, cell culture, cryopreservation, purification, filling, visual inspection, and aseptic processing highly preferred.
  • Ability to work independently and stay on task in a fast-paced environment without direct supervision
  • Knowledge of cGMP/FDA regulations, quality standards, documentation and practices.
  • Ability to perform physical tasks requiring dexterity and mobility. Daily tasks call for routine walking, standing in cleanroom environments with appropriate PPE and occasional lifting of heavy materials.
  • Must have experience in drafting and reviewing technical documents with strong technical writing skill.
  • Expertise in aseptic/sterile techniques and familiarity with cell culture equipment.
  • Strong critical thinking, troubleshooting, and problem-solving abilities.
  • Self-motivated with a willingness to undertake temporary responsibilities beyond the initial job description.

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